Document text
Principal Investigator: Matthew Hamill
Organization: JOHNS HOPKINS UNIVERSITY
Fiscal Year: 2024
Award: $500,514
Funding agency: National Institute of Biomedical Imaging and Bioengineering
Clinical Core Project Summary
The long-term goal of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases (JH-C[ID]2)
is to accelerate infectious disease diagnostic point-of-care (POC) technology innovation and access to impact
global public health. Diagnostic advances in vitro devices (IVD) during the COVID-19 pandemic have propelled
development of point-of-care (POC) platforms for sexually transmitted infections (STI) and other emerging and
re-emerging infectious diseases. The public has embraced self-testing and used it to assess their ‘status’ for
SARS-CoV-2 infection. However, thoughtful evaluation of the performance and implementation of STI POC tests
(POCT) is necessary to avoid losing the gains in patient care and public health provided by well-established,
centralized testing within a healthcare setting. In order to responsibly accelerate the development of POC and
at-home self-tests, companies need access to clinical expertise to refine use case and intended use so that POC
tests are complementary and increase access to diagnostic certainty. Over the last 3 cycles of our POCTRN
Center, developers have valued the JH-C[ID]2 resources including the availability of specific types of samples
and sample formats to validate their technology at all stages of development. We have previously established
clinical sites in diverse, ‘real-world’ settings where POCTs are the most impactful: emergency department (Johns
Hopkins), ambulatory settings for adults (John G. Bartlett Specialty Practice, Baltimore City Health Department
[BCHD]) and adolescents (Cincinnati Children’s Adolescent Clinic), pharmacies, and resource-limited settings
(Infectious Diseases Institute (IDI), Kampala, Uganda). In this U54 cycle, we will be poised to perform pre-clinical
pilots and iterative prospective evaluations of performance to identify IVD that can be successfully
commercialized and adopted by the public, or that need further refinement or removal from the pipeline (go/no-
go decisions). The Core’s experienced Investigators will verify diagnostic performance by evaluating the
technology at Johns Hopkins, serve on the Clinical Review Committee to provide developers’ access to clinical
expertise, enlarge the number of samples available for iterative development, and provide our clinical sites for
pre-clinical pilots. The Clinical Core will: 1) evaluate the diagnostic performance of prototype POC devices for
STIs and emerging and re-emerging infectious diseases in intended populations; 2) provide clinical and
regulatory expertise through the Clinical Review Committee; and 3) evaluate acceptability and usability and end-
users test experience and preference for POC tests as well as their feasibility within clinical workflows. As the
oldest and well-established POCTRN Center, our model of POC test development support has led to the FDA
clearance or emergency use authorization of numerous STI and COVID-19 in vitro devices. The JH-C[ID]2 is
well-positioned to continue to catalyze the successful development of POC and self-tests for STIs, as well as
emerging and re-emerging infections.
Terms: <0-11 years old><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><21+ years old><AIDS Virus><Abscission><Acceleration><Accident and Emergency department><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Adolescent><Adolescent Youth><Adopted><Adult><Adult Human><Assay><Bacterial Vaginitis><Bacterial Vaginosis><Baltimore><Bioassay><Biological Assay><Businesses><C trachomatis><C. trachomatis><COVID crisis><COVID epidemic><COVID pandemic><COVID-19><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 infection><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 virus><COVID-19 virus infection><COVID-19 years><COVID19 infection><COVID19 virus><CV-19><Child><Child Youth><Childhood><Children (0-21)><Chlamydia trachomatis><Cities><Clinic><Clinical><Clinical Research><Clinical Study><CoV-2><CoV2><Collection><Communicable Diseases><Communities><Community Pharmacy><Coronaviridae><Coronavirus><Coronavirus Infectious Disease 2019><Data><Development><Devices><Diagnostic><Emergency Department><Emergency Medicine><Emergency room><Emerging Communicable Diseases><Emerging Infectious Diseases><Emerging infection><Evaluation><Excision><Extirpation><FDA EUA><FDA Emergency Use Authorization><Feedback><Food and Drug Administration EUA><Food and Drug Administration Emergency Use Authorization><Freezing><Goals><Gonococcus><HIV><HSV><Health><Herpes Simplex Virus><Herpes labialis Virus><Home><Human Immunodeficiency Viruses><IRB><IRBs><In Vitro><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Institutional Review Boards><Internet><Investigators><LAV-HTLV-III><Link><Low-resource area><Low-resource community><Low-resource environment><Low-resource region><Low-resource setting><Lymphadenopathy-Associated Virus><M genitalium><M. genitalium><Modeling><Monkey Pox><Monkeypox><Mycoplasma genitalium><N gonorrhea><N gonorrhoeae><N. gonorrhea><N. gonorrhoeae><NIH><National Institutes of Health><Neisseria gonorrhea><Neisseria gonorrhoeae><Nonspecific Vaginitis><Patient Care><Patient Care Delivery><Patient Recruitments><Performance><Pharmacies><Pharmacy facility><Pilot Projects><Point of Care Technology><Population><Position><Positioning Attribute><Protocol><Protocols documentation><Public Health><RADx Tech><Rapid Acceleration of Diagnostics Tech><Rapid Acceleration of Diagnostics Technology><Removal><Research><Research Design><Research Personnel><Research Resources><Researchers><Resistance><Resource-constrained area><Resource-constrained community><Resource-constrained environment><Resource-constrained region><Resource-constrained setting><Resource-limited area><Resource-limited community><Resource-limited environment><Resource-limited region><Resource-limited setting><Resource-poor area><Resource-poor community><Resource-poor environment><Resource-poor 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